The Canadian Market and Regulations. Are The Leading Brands Really Better Quality?
THE CANADIAN MARKET AND REGULATIONS
Canada, like the rest of the world, was not ready for a global pandemic and when it hit, Canada had to scramble to execute on an essentially nonexistent stockpile program for Personal Protective Equipment (“PPE”). This does not come as a surprise, our government does not necessarily have the reputation of being proactive, and a global pandemic is the absolute worst time to start shopping for emergency supplies. In turn, Canada found itself competing with dozens of other countries and private U.S. hospital networks to acquire the most sought-after items like N95s.
Where are we now? Well, I guess you can say the situation should have improved with some of the measures put in place by Health Canada – allowing the use of “commercial grade” N95’s in a healthcare setting and expanding the list of medical devices for exceptional importation and sale. Which translates expanding the N95s that are allowed to be sold in Canada and in a healthcare setting. However, healthcare institutions have not sufficiently taken advantage of these measures because of the stigma created around “Chinese made masks” but when you really think about it – masks have always been prominent in Asian culture, and in turn, they have well-established manufacturers producing some of the best quality out there.
On that note, the measures put in place are also important considerations for those who oversee procurement. If you are considering purchasing a N95 model that is manufactured outside of North America, it must be included on the List of Medical Devices for Exceptional Importation and Sales. It also should be noted that not everyone can just start importing or selling the respective models on this list. Companies that have a class 1 MDEL submit an application for what’s called an Interim Order (to have the product listed and for Health Canada to allow it to be imported). This requires Health Canada to have correspondence with the respective manufacturer to verify that the MDEL holder/company is an authorized representative of the manufacturer. This provides a mechanism to prevent counterfeits from entering the Canadian Market. If an organization purchases a N95 that is not on the list or from a supplier not associated with the authorized importer, it is subject to Health Canada pulling that inventory off the shelves. Obviously, the same goes if a N95 does not meet NIOSH standards.
As I mentioned, one would think the situation should have improved almost a year into the pandemic and Health Canada enabling other products to enter the Canadian market but in many ways, things have only gotten worse. There are a few reasons contributing to this, including:
1) 93% of 3M’s inventory is dedicated to American frontlines, resulting in some of Canada’s largest buyers only receiving a fraction of which they normally do.
2) Health Canada is not a certification body for N95s and uses NIOSH specifications as the gold standard in Canada.
3) NIOSH has paused certifying any N95s manufactured outside of the U.S. and in turn, Canadian N95 manufacturers that have come online during the pandemic are unable to service the healthcare market.
4) Given the supply shortage, there is a completely new dynamic for individuals in charge of procurement causing inefficiencies in securing the viable alternative options available (reluctancy to change and lack of knowledge on evaluating products).
5) Behind the scenes and a significant bottleneck is the scarcity of the raw materials to produce masks.
6) Health Canada is currently backlogged with inquiries; getting new products to market is very slow right now. We submitted an IO for our Zhongyi products 3 months ago and still haven’t heard anything.
To make matters worst, there is a Global trend of Public Health Officials encouraging the general public to wear medical-grade masks (including N95s) to combat the new, more contagious strains of COVID-19. Not the smartest move, considering we have yet to overcome the current shortage for our frontline workers, who are most vulnerable.
The shortage is alive and well, but the situation can be greatly improved by fully utilizing all of the viable N95s available in the market, not just 3M. This requires raising awareness and educating people in charge of procuring N95s, hence why I am currently writing this article.
Let’s get right into the root of the problem. There are many misconceptions around N95s and this has had implications on the severity of the shortage. Everyday on the news, there is a new story of a healthcare institution not having an adequate supply of N95s. This leaves suppliers like us, scratching our heads as we’ve been in contact with that same institution, prior.
Misconception #1: 3M is superior to all other N95s
Canada’s dependency on 3M is two-fold. A majority of healthcare institutions have generally only used 3M in the past and have no awareness of the other brands – leading the perception that 3M is the gold standard and only brand suitable for medical use. This in turn, has deterred the ability of the respective individuals responsible for procurement to properly evaluate other N95 brands they’re not familiar with.
Many individuals responsible for procurement have succumbed to paying high premiums for the 3M masks they’ve been using for years and rolling the dice on a very volatile supply. In my own experience, I’ve had healthcare institutions respond or contact me because they are in need of supply, however, they are only interested in 3M and won’t even blink at our offering. There is no question that 3M is a great brand, however, when you compare the Respiratory Assessment Results, there are brands and models, including Dasheng and Zhongyi that perform the same, or better. This information is published on the CDC website if you don’t have access to the actual testing reports. This is step one in evaluating the quality of N95 respirators. Customers ask, “will these other masks protect my staff just as well as 3M mask?” and our answer is yes, maybe even more.
Misconception #2: The 3M plant going up in Canada is going to be the save-all and it’s just around the corner.
Additionally, as you may have heard, the government and 3M have an agreement to start producing masks in Canada. This has gotten everyone’s hopes up a little too high. For one, we have no timeline of when the plant will finish construction, let alone be operational. I did a Google search and nothing has been published since the initial announcement in August. Does anyone know? All I know is that it is not an easy task to just start producing masks, and that after the facility has been built, it will take some time before operations begin. From our understanding, this is a completely new facility and regulatory bodies see it that way too. All certifications are on a factory to factory basis and not the company as a whole.
That leads to my next point that it takes a factory months of testing, retooling, and being operational to meet regulatory requirements, not to mention existing administrative burden on regulatory bodies. Even once the factory starts producing N95s (which they say April 2021), the Federal and Ontario governments own all the inventory. Do you know how they will allocate it? Will we still have access to our American supply? Likely not, 3M will never be able to produce enough mask for the U.S. because there is not enough raw materials to go around for 3M to produce on that scale. The point is no one knows when production will actually start nor how supply will be distributed. Too many healthcare institutions are relying on this and will be back in the same situation, scrambling to find a viable supply.
Misconception #3: Masks made in China are too risky because of counterfeits.
The first being, North America’s love-hate relationship with China. If you Google Dasheng (one our brands), the search engine is littered with publications around counterfeits that were issued to Healthcare workers in the U.S. This doesn’t exactly give buyers confidence in the brand and has been a key driver in the reluctance to change. Counterfeits exist for every brand, if you heard in recent news 3M counterfeits have recently flooded the North American market, including the Canadian Government stockpile.
How do you mitigate the risk of counterfeits? Well, Health Canada has already done that for you with the List of Medical Devices for Exceptional Importation and Sales. There are also other ways, including:
1) Factory certificates.
2) Confirming lot number with manufacturers – Dasheng has an email address where lot numbers can be verified – [email protected] and you can also use the CDC/NIOSH website to look up lot numbers.
3) Suppliers will likely have a letter from the manufacturer verifying they are an authorized representative – required for Health Canada.
4) Suppliers like RMHS, who are manufacturer direct can have the shipment sent directly from the manufacturer.
There is no risk if you do your proper due diligence.
Misconception #4: The need of the same styles/designs that make up my current inventory when switching brands. This is a perfect segue for the next section of the blog; Model Designs and Fitting.
Although the approach of trying to replicate your current make up of N95s is not all bad, it provides a good foundation and starting point, and if all goes smoothly, it makes for an easy transition. The issue is that all masks fit differently even when similar in design. The best approach is to look at it from a size demographic perspective. This will enable you to consider other designs that are meant to fit the same demographic. I understand that it’s quite the undertaking, but it has potential, not only for securing a reliable supplier but also improving your inventory make up. For example, having less SKUs to deal with.
MODEL DESIGNS AND FITTING
Every N95 fits differently and the end users vary by institution. There is no perfect formula to predict the outcomes of the fit testing. With that being said, there are certain designs (universal fold) that have a better ability to fit across multiple face sizes and structures, while other designs (cup) are more customized to fit a specific size demographic.
NIOSH has conducted several studies evaluating different designs and how they fit on diverse sample size of individuals. The studies included the four generic design categories:
1) Small Cup Design (Dasheng DTC3W)
2) Medium/Large Cup Design (Dasheng DTC3M-1 and ZYB-11)
3) Trifold Model (Dasheng DTC3Z)
4) Duckbill (Dasheng DTC3B)
5) Vertical Fold (ZYE-02)
The following is the findings in the studies, while leveraging my own experiences and data confirming the findings on each of the design categories.
- Small Cup Design
This is a highly sought after design to fit the smaller-face structure demographic, such as woman. Small cups were the second-best fitting design in the studies, generally having a passing rate in the 60 or 70 percentile. Although cups are intended for a more customized fit, smaller masks in general tend to fit better, stretching and creating a tighter seal. The issue and one may consider, is that the end users typically find the design uncomfortable having to wear it for hours at a time. Cups have higher seal pressures and do not provide as much flexibility as a fold style design to fit the face more comfortably – just think of a suction cup. There is also a misconception that the higher seal pressures that cups offer translates to better protection and seal. However, based on NIOSH studies, the higher seal pressures actually impede its fitting ability.
Anyways, that’s not to say cups aren’t important to include in your inventory but it will take a large number of SKUs to accommodate all end users with cups. Our DTC3W is our second most popular model as it has sufficed as a viable alternative for the high in demand 3M 1860S. And, we are excited to introduce our Zhongyi ZYB-11 as it is a universal cup, intentionally designed to fit a larger demographic by addressing some of the issues above. According to NIOSH, the universal design cups are able to fit across 3-4 face size panels, while cups with specified sizes can only fit across 1 or 2.
- Medium/Large Cups
The second worst fitting design. A good fitting Medium/Large cup is hard to come by. Many of them are just too large to create a seal on a large majority of the population. It is recommended to consider a universal cup like our Zhongyi ZYB-11, mentioned previously. However, medium and large cups should not be disregarded as they may be a viable option for the larger end-users that have difficulty fitting to other models.
- Trifold Model
The trifold model is superior when it comes to fitting. Our DTC3Z model is by far our most popular, used by Provincial Health Agencies and large hospitals across the country. The trifold model is designed to fit across all face sizes in the normal distribution. The studies concluded on average this design has 90% passing rate. We’ve collected some our own fit testing data and the DTC3Z has passing rate of 98%. This data was from a specific sample and the results can vary. That being said, we have only had positive feedback on fit testing, so we can assume others experiencing similar results.
The best way to sum up the Duckbill design is practical, which doesn’t translate to its fitting ability. It’s comfortable and offering the highest protection. They are generally classified as surgical grade (FDA 510), like our DTC3B model is. According to the NIOSH studies, these models on average have passing rate of 20-30%. Again, the biggest appeal is the comfort (minimal face contact and more breathable) and it is intentionally designed to offer highest protection in a surgical environment.
- Vertical Fold
This wasn’t included in the categories but it is important to touch on as it is a great fitting design if it comes from a reputable manufacturer such as ours, Zhongyi. Empirically vertical folds are great fitting masks.
Vertical folds have gotten a bad reputation as the market they are often associated with KN95s (in North America, KN95s are not used in a healthcare environment – so you will likely come across a KN95 if you go to a local pharmacy, sold to the general public). However, based on studies, the vertical fold design actually provides for high performance – maintaining filter efficiency and seal longer.
What should be your approach?
What I generally suggest to clients is starting with the universal flat fold designs (ex. DTC3Z and ZYE 02), the combination of the two should make up for a majority of your inventory based on fit testing and user preferability. From there, you would work your way to cups targeting certain face demographics that weren’t successful with other models. Finally, consider the duckbill as an alternative option, the user preference is high if the model fits properly.
If you are only looking to replace a single model, then the comparison approach is most efficient and testing a design similar to the one you are replacing. And finally, having a universal fold model such as the DTC3Z is critical and will enable you to potentially reduce your SKUs, in turn, simplifying the procurement process.
Fit testing in general can be sometimes challenging and interspersed with occasional failed results which requires retesting. Fit testing is a very onerous process and procurement managers are reluctant to go through with it. This is the absolute wrong approach, you have to look at this for the long-term. The shortage is not going to subside anytime soon or even after we overcome the pandemic as a society.
OUR PRODUCTS AND APPROACH
RMHS offers six different N95 models, all trusted by healthcare institutions across North America. Our Dasheng DTC3Z model is particularly popular in the Canadian Market being used by Provincial Health Authorities, major hospitals and long-term care homes. Our SKU make up is intentional, including all the most popular styles of models that fit a wide variety of individuals. The quality standards of our N95s are in the top tier in the likes of the most well-known manufacturers. Both Dasheng and Zhongyi have been in operations for over 15 years and are top brands in other markets globally. I have no doubt you will be very familiar with these brands in a few months.
The best part of our offering is that we are manufacturer direct. This enables us to work with some of Canada’s largest buyers and fulfill large requirements and have access to inventory at ex-factory costing to provide bottom quartile pricing. We can also get you into the production schedule and you will never have to worry about a shortage of supply.
When working with healthcare institutions, we like to provide more than a product offering. We understand it can be difficult navigating this new market dynamic and regulatory environment – so we ensure that we are able to educate our clients so that they can make informed decisions and be confident in those decisions. We provide transparent information and don’t over promise. Logistics, especially in the world of today, is never perfect. That’s not to say we are slow on delivery – we can typically get our clients their products in 10-14 days, and that’s if it is coming off the production lines in China.
Just to be clear, we don’t have anything against 3M. We just think it is important that everyone understands the reality of how scarce the supply is. The Canadian market cannot depend solely on 3M and the perception that it is the only viable option. This has amplified the shortage. Plus, now that you know they are not superior, do you really want to pay $6-7 per mask or be put in a situation of potentially risking the safety of your staff?
To conclude, RMHS will continue to strive and ensure our healthcare institutions have access to a viable supply and more reasonably priced N95s. We are constantly seeking ways to better service our clients by improving our product offering and staying informed on market information and trends. We take in pride in ensuring our healthcare workers and first responders who are risking their lives for others are protected.
If you have any questions regarding N95s, you know who to call! Please check out our products page to have a closer look at our N95 stock.G